A Phase III, Double-blind, Randomized, Parallel Group, Placebo-controlled Study of Oral Fosamax, 70 mg Once a Week, for the Prevention of Androgen Deprivation Bone Loss in Non-metastatic Prostate Cancer
18 Years
N/A
Male
Osteoporosis
Trial Information
A Phase III, Double-blind, Randomized, Parallel Group, Placebo-controlled Study of Oral Fosamax, 70 mg Once a Week, for the Prevention of Androgen Deprivation Bone Loss in Non-metastatic Prostate Cancer
This is a phase three multicentre, double blind, randomize parallel group,
placebo-controlled study in 250 men with histologically proven cancer without bone
metastases who are beginning ADT therapy and who will receive a concomitant treatment with
either oral Fosamax 70 mg once a weak (n=125) or placebo (n=125) for one year. Changes in
BMD, markers of bone absorption and formation are monitored.
Inclusion Criteria:
- Histologically/cytologically proven, non-metastatic (M0) adenocarcinoma of the
prostate.
- Life expectancy of > 12 months.
- Initiation of treatment with the luteinizing hormone-releasing hormone agonist
(LHRH-a) Lupron no more than 15 days prior or 30 days following, baseline visit.
- Requiring treatment with LHRH agonists for prostate cancer, for a duration of at
least 12 months from baseline.
- Eastern Cooperative Oncology Group (ECOG) performance status 0, 1 or 2
- Prior to any study-specific procedures, subject (and/or their legally authorized
representative) has voluntarily signed and dated an informed consent form.
Exclusion Criteria:
Bone Metastases Current or previous use with in past 12 months of bisphosphonate. Known
hypersensitivity to LHRH. Hypocalcaemia. Severe renal impairment, Abnormal liver function,
Hypothyroidism, Hyperthyroidism, Bilateral hip replacement.
Use of LHRH or anti-androgen medication within last 12 months. Abnormalities of esophagus
which delay esophageal emptying. Inability to stand or sit upright for at least 30
minutes.
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention
Outcome Measure:
Bone mineral density
Outcome Time Frame:
ONE YEAR
Safety Issue:
No
Principal Investigator
Lesley Carr, M.D.
Investigator Role:
Principal Investigator
Investigator Affiliation:
Sunnybrook Health Sciences Centre
Authority:
Canada: Health Canada
Study ID:
ACA-CANA-04-012
NCT ID:
NCT00236002
Start Date:
July 2005
Completion Date:
August 2009
Related Keywords:
- Osteoporosis
- Osteoporosis
Name | Location |
|---|
